The study objective is to evaluate long-term outcomes for participants enrolled in the ROADSTER 3 study and treated with the ENROUTE Transcarotid Stent System (TSS) and ENROUTE Transcarotid Neuroprotection System (NPS).
This is an open label, single arm, multi-center post-market study evaluating long-term outcomes for participants at standard risk for adverse events from carotid endarterectomy who underwent carotid revascularization with the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System in the ROADSTER 3 study.
Study Type
OBSERVATIONAL
Enrollment
197
Carotid artery revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent
Ipsilateral Stroke
Ipsilateral stroke at 2-years, 3-years, 4-years, and 5-years following the index procedure
Time frame: 2-years, 3-years, 4-years, and 5-years following the index procedure
Ipsilateral Stroke Mortality
Ipsilateral stroke mortality at 2-years, 3-years, 4-years, and 5-years following the index procedure
Time frame: 2-years, 3-years, 4-years, and 5-years following the index procedure
In-stent Restenosis
In-stent restenosis ≥70% at 2-years and 5-years
Time frame: 2-years and 5-years following the index procedure
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